← Back to Search

Neurosteroid

Allopregnanolone for Traumatic Brain Injury (ALLO Trial)

Phase 2
Waitlist Available
Led By Christine E. Marx, MD MA
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
confusion or disorientation
BPI (Brief Pain Inventory, Short Form) 'current' pain intensity rating item score 4 (scale of 0-10) for musculoskeletal pain
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 hours, 24 hours, 7 days, and 14 days
Awards & highlights

ALLO Trial Summary

This trial will test if allopregnanolone can improve symptoms of depression and pain in patients with a history of mild traumatic brain injury.

Who is the study for?
This trial is for U.S. Military veterans aged 21-62 who have had a mild traumatic brain injury since 2001 and suffer from moderate depression (HAM-D score of at least 14) and musculoskeletal pain (BPI rating of at least 4). Participants must not be planning to change psychiatric medications or treatments during the study.Check my eligibility
What is being tested?
The trial tests whether allopregnanolone, given through an IV, can help with depression and pain in those with past mild TBI. It compares this treatment against a placebo. The main goal is to see if it improves mood and pain, with a secondary focus on overall function.See study design
What are the potential side effects?
Possible side effects are not detailed here but could include reactions related to intravenous infusions or specific effects of allopregnanolone which may affect mood, cognition, or physical well-being.

ALLO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I experience confusion or disorientation.
Select...
My current pain level for musculoskeletal issues is at least a 4 out of 10.
Select...
My pain is related to muscles or bones.
Select...
I served in the U.S. Military after 9/11 and have had a mild traumatic brain injury since 2001.
Select...
I have been diagnosed with major depressive disorder.
Select...
I have lost consciousness for no more than 30 minutes.

ALLO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 hours, 24 hours, 7 days, and 14 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 hours, 24 hours, 7 days, and 14 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Brief Pain Inventory, Short Form (BPI-SF) Change
Hamilton-Depression Inventory (HAM-D) Change
Secondary outcome measures
Short Form Health Survey (SF-36) Change

ALLO Trial Design

3Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment1 Intervention
ALLO 0 nM (placebo: loading dose, 4-hour infusion, taper)
Group II: ALLO 50 nMExperimental Treatment1 Intervention
ALLO 50 nM (lower dose ALLO: loading dose, 4 hour infusion, taper)
Group III: ALLO 150 nMExperimental Treatment1 Intervention
ALLO 150 nM (higher dose ALLO: loading dose, 4 hour infusion, taper)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Allopregnanolone
2019
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,321 Total Patients Enrolled
Christine E. Marx, MD MAPrincipal InvestigatorDurham VA Medical Center, Durham, NC
3 Previous Clinical Trials
362 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other empirical evaluations have been conducted pertaining to Allopregnanolone?

"Currently, there are 5 trials involving Allopregnanolone underway. None of them have progressed to Phase 3 yet and all the research sites for this treatment are located in Durham, North carolina."

Answered by AI

Does this clinical trial allow for those aged 20 and above to participate?

"This trial is only open to participants aged 21-62 years. Conversely, there are 61 trials catered towards minors and 227 for those above retirement age."

Answered by AI

Is admission to this experiment still possible?

"This study is not currently accepting candidates. It was first posted on January 1st 2023 and its last update was July 14th 2022. If you are searching for additional opportunities, there are 311 trials concerning traumatic brain injury (TBI) and 5 research projects associated with Allopregnanolone that require participants."

Answered by AI

How many enrollees has this research project accepted thus far?

"This clinical trial has closed its recruitment, having first been posted on the 1st of January 2023 and last updated on July 14th 2022. As an alternative, there are 311 studies searching for individuals with traumatic brain injury (TBI) and 5 trials which require patients to take Allopregnanolone."

Answered by AI

Has Allopregnanolone gained regulatory approval yet?

"Our team has rated Allopregnanolone's safety as a 2, since this trial is still in its second phase and no efficacy data exists yet."

Answered by AI

Is there an opportunity for me to be involved in this research?

"For this clinical trial, 132 participants between 21 to 62 years of age are sought that have experienced a traumatic brain injury (TBI). Further requirements include: disorientation or confusion, loss of consciousness for less than 30 minutes, post-traumatic amnesia lasting fewer than 24 hours, HAM-D score 14 indicative of moderate depression; history of mild TBI since 2001 and service in the US Military after 9/11/2001; no psychotic features; transient neurological abnormalities such as focal signs but without needing surgery."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
Florida
How old are they?
18 - 65
What site did they apply to?
Durham VA Medical Center, Durham, NC
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

TBI symptoms have gotten worse.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Allopregnanolone in Chronic Complex Traumatic Brain Injury
2024. "Allopregnanolone in Chronic Complex Traumatic Brain Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04003285.
All > Tbi > Traumatic Brain Injury
~88 spots leftby Sep 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top